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Набор скоро начнётся NCT07519473

Neuromuscular Versus Resistance Training on Functional Capacity in Patients With Heart Failure.

Без фазы С лечением Heart Failure

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Resistance Training, Neuromuscular Training.
Кому может быть актуально
Состояния в реестре: Heart Failure. Базовые параметры: 40 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Пакистан
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Comparative Effects Between Neuromuscular Versus Resistance Training on Functional Capacity, Cardiorespiratory Fitness, and Lower Limb Performance in Patients With Heart Failure.

Обзор

This randomized controlled trial will compare the effects of neuromuscular training and resistance training on functional capacity, cardiorespiratory fitness, and lower limb performance in patients with chronic heart failure. A total of 40 participants will be randomly assigned into two groups in a single-blinded design. Both groups will undergo a 10-week supervised exercise program. Outcomes will be assessed using VO₂ peak, 6-Minute Walk Test (6MWT), Short Physical Performance Battery (SPPB), and quality of life measures. The study aims to determine the more effective rehabilitation approach for improving clinical outcomes in heart failure patients.

Подробное описание

Heart failure is a chronic and progressive condition associated with reduced functional capacity, impaired cardiorespiratory fitness, and decreased lower limb performance, significantly affecting quality of life. Exercise-based cardiac rehabilitation is an established intervention; however, the comparative effectiveness of different exercise modalities, particularly neuromuscular training and resistance training, remains insufficiently explored.

This study is a single-blinded randomized controlled trial designed to compare the effects of neuromuscular training and resistance training on functional capacity, cardiorespiratory fitness, and lower limb performance in patients with chronic heart failure. A total of 40 participants meeting the inclusion criteria will be recruited from tertiary care hospitals and cardiac rehabilitation centers. After baseline assessment, participants will be randomly allocated into two groups using a concealed allocation method.

Both groups will undergo a supervised 10-week intervention program consisting of 20 sessions (2 sessions per week). Each session will include warm-up, 20 minutes of specific training, 20 minutes of moderate-intensity aerobic exercise, and cool-down. The resistance training group will perform exercises targeting major muscle groups at moderate intensity (50-70% of one-repetition maximum), while the neuromuscular training group will focus on balance, coordination, proprioception, and motor control using structured functional exercises.

Primary outcome measures will include cardiorespiratory fitness (VO₂ peak assessed via Chester Step Test), functional capacity (6-Minute Walk Test), and lower limb performance (Short Physical Performance Battery). Secondary outcomes will include resting heart rate, blood pressure, oxygen saturation, perceived exertion (Borg CR-10), and quality of life measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ).

Assessments will be conducted at baseline and after completion of the intervention by a blinded assessor to minimize bias. Data will be analyzed using appropriate statistical methods to compare within-group and between-group differences.

This study aims to generate evidence on the comparative effectiveness of neuromuscular and resistance training, which may help in optimizing cardiac rehabilitation protocols and improving clinical outcomes in patients with heart failure.

Вмешательства

  • Поведенческое Resistance Training
    A supervised resistance training program targeting major muscle groups using resistance bands, machines, and bodyweight exercises. Training intensity will be set at 50-70% of one-repetition maximum and progressed based on patient tolerance. Each session will include warm-up, 20 minutes of resistance exercises, 20 minutes of moderate-intensity aerobic exercise, and cool-down. Sessions will be conducted twice weekly for 10 weeks.
  • Поведенческое Neuromuscular Training
    A supervised neuromuscular training program focusing on balance, coordination, proprioception, and postural control. Exercises will include dynamic balance tasks, limb coordination, and training on unstable surfaces. Each session will include warm-up, 20 minutes of neuromuscular exercises, 20 minutes of moderate-intensity aerobic exercise, and cool-down. Sessions will be conducted twice weekly for 10 weeks.

Первичные конечные точки

  • Functional Capacity [Срок оценки: Baseline and after 10 weeks of intervention]
  • Cardiorespiratory Fitness (VO₂ Peak) [Срок оценки: Baseline and after 10 weeks of intervention]
  • Lower Limb Performance [Срок оценки: Baseline and after 10 weeks of intervention]

Критерии участия

Критерии включения

  • Male and female patients aged 40-60 years
  • Diagnosed with chronic heart failure ≥ 1 year
  • Heart failure with reduced ejection fraction (HFrEF), EF ≤ 40%
  • NYHA Class II-III
  • Low to moderate exercise risk (based on Chester Step Test)
  • On stable pharmacological treatment for ≥ 6 weeks
  • Able to understand and follow exercise instructions

Критерии исключения

  • Absolute contraindications to exercise (e.g., recent MI, unstable angina, uncontrolled arrhythmias, severe aortic stenosis, decompensated HF)
  • Abnormal CPET findings (severe arrhythmias, ischemia, ST depression)
  • Abnormal blood pressure response during exercise
  • Exercise-induced angina or thoracic pain
  • Musculoskeletal, neurological, or cognitive impairments limiting exercise participation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Пакистан · 1 центр
  • community based Cardiac Rehab Unit, Cardiac Centers, and Tertiary Care Hospitals — Lahore

Идентификаторы

NCT: NCT07519473 · REC/RCR & AHS/25/0321

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗